The Effect of Human Albumin on Coagulation Competence and Hemorrhage
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 21, 2014
October 1, 2014
1 year
September 27, 2014
October 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of coagulation during surgery and in the recovery room
Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude
up to 1 day after surgery
Secondary Outcomes (2)
Measurement of postoperative surgical complications
From date of operation up to 1 months postoperatvely
Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room
up to 1 day after surgery
Study Arms (2)
Human Albumin " Behring"
ACTIVE COMPARATORInfusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Lactated Ringer
PLACEBO COMPARATORInfusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Interventions
Intravenous infusion of 5% Human Albumin during major surgery
Intravenous infusion of Lactated Ringer during major surgery
Eligibility Criteria
You may qualify if:
- Patient more than 18 years old
- Indication for elective post-renal operation including cystectomy
- Patient without anticoagulative, acetylsalicylic acid or nonsteroidal antiinflammatory drug
- treatment for the last 5 days
You may not qualify if:
- Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
- Pregnant or nursing
- Allergic to Human Albumin
- Disturbance in electrolytes
- Patient under committee
- Patient joining another trial interfering the actual trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Mar;95(9):e2720. doi: 10.1097/MD.0000000000002720.
PMID: 26945358DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Niels H Secher, MD PHD Prof
Rigshospitalet, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Specialist in Surgery
Study Record Dates
First Submitted
September 27, 2014
First Posted
October 21, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
October 21, 2014
Record last verified: 2014-10